Technological products portfolio
ATLAS
2-100µm particle analysis solution (SubVP) using imaging techniques
Investment: €115k
Scope: Health
Scientific field(s): Mathematics, STIC and nanotechnology
Institution(s): Université d'Évry
Development: Transfer in progress/completed to industrial partner BD
USE CASES
The biophysical characterization of subvisible particles in a drug stored in pharmaceutical containers is very difficult. Particles are present in all biopharmaceutical samples and can come from various sources: production processes, formulation excipients, biomolecule degradation products, container components, environmental particulate impurities, etc. The morphology, color, and size of these particles, examined using control tools such as MFI, FlowCam, etc., will therefore vary greatly depending on their nature.
However, today’s pharmaceutical industries are demanding ever more information about the nature of the particles in their products in order to support development and accelerate the market launch of new biomolecules. On the one hand, image interpretation requires a qualified specialist; on the other hand, quality control requires a decision to reject or accept the batch within a few minutes.
ADVANTAGES
Thus, image interpretation is in reality only a quick glance at thumbnails by the specialist, without the possibility of an in-depth evaluation. An automatic method for identifying the particle would improve image interpretation and productivity by providing numerical values for the relevant parameters instead of the approximations currently used. The advantages of the proposed methodology are:
– The systematization of the process through artificial intelligence;
– The homogeneous nature of the interpretation, reducing variability in interpretations;
– The improvement of medical and economic efficiency.
APPLICATIONS
Imaging is commonly used as a characterization method in the pharmaceutical industry, particularly to identify and quantify subvisible particles (SubVPs) in solid and liquid formulations. Therapeutic proteins such as monoclonal antibodies (mAbs) are used for various diseases, including cancer.
SubVP concentration is one of the critical quality attributes (CQA) that must be monitored during the development of biomolecule formulations and for their marketing. This is because biomolecules tend to degrade and form aggregates when exposed to interfaces, heat, or mechanical stress that may occur during drug production, shipping, or storage. Aggregate formation can lead to loss of efficacy or, more importantly, safety issues for patients, such as an undesirable immune response.
This is why controlling particle concentration (<100 µm or SubVP) is very important from a regulatory standpoint.